Strictly speaking, laboratories in the US are required to adhere to Good Laboratory Practices (GLP) as described by the FDA or EPA only if they are studying test articles (FDA) or test substances (EPA) in a test system under laboratory conditions. Certainly if your testing falls into this category, GLP must be followed. But there is often confusion as to whether particular laboratory activities must comply with GLP. Sometimes a laboratory’s potential customers will insist that they follow GLP, even though GLP is not applicable. If you are in this situation, you need to implement GLP such that it provides the most value with the least cost to your company.
Globiox can analyze the type of testing done in your laboratory and determine if the appropriate regulations are GMP, GLP, GCP, or CLIA (in the US). If GLP is the appropriate regulation, or if customers are insisting on it, Globiox subject matter experts can help you organize and implement GLP processes so that they have the most value and least cost to you. The key element to this type of organization is defining what constitutes a Study in your laboratory. Globiox can also train and certify your Study Directors through our Study Director Certification Program, which we will customize for your organization.